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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019101
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENTANYL CITRATE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription AP Yes Yes
FENTANYL CITRATE FENTANYL CITRATE EQ 0.025MG BASE/0.5ML INJECTABLE;INJECTION Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/11/1984 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/15/2023 SUPPL-63 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019101s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019101Orig1s063ltr.pdf
03/03/2023 SUPPL-61 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.
01/20/2023 SUPPL-60 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019101Orig1s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019101Orig1s060ltr.pdf
10/08/2019 SUPPL-51 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019101s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019101Orig1s051ltr.pdf
01/24/2019 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019101s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019101Orig1s047ltr.pdf
12/16/2016 SUPPL-45 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019101s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019101Orig1s045ltr.pdf
05/26/2016 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.
02/12/2016 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.
11/09/2015 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.
01/20/2015 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.
05/21/2014 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.
03/20/2014 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.
02/06/2013 SUPPL-37 Labeling

Label is not available on this site.
02/13/2012 SUPPL-33 Labeling

Label is not available on this site.
02/25/2010 SUPPL-31 Labeling

Label is not available on this site.
08/28/2001 SUPPL-20 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.
06/29/2001 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
05/20/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
11/02/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
08/15/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
03/25/1994 SUPPL-15 Labeling

Label is not available on this site.
05/01/1991 SUPPL-14 Labeling

Label is not available on this site.
08/07/1991 SUPPL-13 Labeling

Label is not available on this site.
08/07/1991 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
06/25/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
01/11/1990 SUPPL-10 Labeling

Label is not available on this site.
11/16/1989 SUPPL-9 Labeling

Label is not available on this site.
11/19/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
01/30/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
11/05/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
11/05/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/15/2023 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019101s063lbl.pdf
01/20/2023 SUPPL-60 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019101Orig1s060lbl.pdf
10/08/2019 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019101s051lbl.pdf
01/24/2019 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019101s047lbl.pdf
12/16/2016 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019101s045lbl.pdf
12/16/2016 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019101s045lbl.pdf

FENTANYL CITRATE

INJECTABLE;INJECTION; EQ 0.05MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FENTANYL CITRATE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 212086 FRESENIUS KABI USA
FENTANYL CITRATE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 019101 HIKMA
FENTANYL CITRATE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 019115 HOSPIRA
FENTANYL CITRATE PRESERVATIVE FREE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 210762 FRESENIUS KABI USA
FENTANYL CITRATE PRESERVATIVE FREE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 072786 HOSPIRA
SUBLIMAZE PRESERVATIVE FREE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 016619 RISING
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